EU IVDR 2017/746
Sectors
Articles (113)
Article 78 — Post-market surveillance system of the manufacturerArticle 79 — Post-market surveillance planArticle 80 — Post-market surveillance reportArticle 81 — Periodic safety update reportArticle 82 — Reporting of serious incidents and field safety corrective actionsArticle 83 — Trend reportingArticle 84 — Analysis of serious incidents and field safety corrective actionsArticle 85 — Analysis of vigilance dataArticle 86 — Implementing actsArticle 87 — Electronic system on vigilance and post-market surveillanceArticle 88 — Market surveillance activitiesArticle 89 — Evaluation of devices suspected of presenting an unacceptable risk or other non-complianceArticle 90 — Procedure for dealing with devices presenting an unacceptable risk to health and safetyArticle 91 — Procedure for evaluating national measures at Union levelArticle 92 — Other non-complianceArticle 93 — Preventive health protection measuresArticle 94 — Good administrative practiceArticle 95 — Electronic system on market surveillanceArticle 96 — Competent authoritiesArticle 97 — CooperationArticle 98 — Medical Device Coordination GroupArticle 99 — Tasks of the MDCGArticle 100 — The European Union reference laboratoriesArticle 101 — Device registers and databanksArticle 102 — ConfidentialityArticle 103 — Data protectionArticle 104 — Levying of feesArticle 105 — Funding of activities related to designation and monitoring of notified bodiesArticle 106 — PenaltiesArticle 107 — Committee procedureArticle 108 — Exercise of the delegationArticle 109 — Separate delegated acts for different delegated powersArticle 110 — Transitional provisionsArticle 111 — EvaluationArticle 112 — RepealArticle 113 — Entry into force and date of applicationArticle 1 — Subject matter and scopeArticle 2 — DefinitionsArticle 3 — Regulatory status of productsArticle 4 — Genetic information, counselling and informed consentArticle 5 — Placing on the market and putting into serviceArticle 6 — Distance salesArticle 7 — ClaimsArticle 8 — Use of harmonised standardsArticle 9 — Common specificationsArticle 10 — General obligations of manufacturersArticle 11 — Authorised representativeArticle 12 — Change of authorised representativeArticle 13 — General obligations of importersArticle 14 — General obligations of distributorsArticle 15 — Person responsible for regulatory complianceArticle 16 — Cases in which obligations of manufacturers apply to importers, distributors or other personsArticle 17 — EU declaration of conformityArticle 18 — CE marking of conformityArticle 19 — Devices for special purposesArticle 20 — Parts and componentsArticle 21 — Free movementArticle 22 — Identification within the supply chainArticle 23 — Medical devices nomenclatureArticle 24 — Unique Device Identification systemArticle 25 — UDI databaseArticle 26 — Registration of devicesArticle 27 — Electronic system for registration of economic operatorsArticle 28 — Registration of manufacturers, authorised representatives and importersArticle 29 — Summary of safety and performanceArticle 30 — European database on medical devicesArticle 31 — Authorities responsible for notified bodiesArticle 32 — Requirements relating to notified bodiesArticle 33 — Subsidiaries and subcontractingArticle 34 — Application by conformity assessment bodies for designationArticle 35 — Assessment of the applicationArticle 36 — Nomination of experts for joint assessment of applications for notificationArticle 37 — Language requirementsArticle 38 — Designation and notification procedureArticle 39 — Identification number and list of notified bodiesArticle 40 — Monitoring and re-assessment of notified bodiesArticle 41 — Review of notified body assessment of technical documentation and performance evaluation documentationArticle 42 — Changes to designations and notificationsArticle 43 — Challenge to the competence of notified bodiesArticle 44 — Peer review and exchange of experience between authorities responsible for notified bodiesArticle 45 — Coordination of notified bodiesArticle 46 — List of standard feesArticle 47 — Classification of devicesArticle 48 — Conformity assessment proceduresArticle 49 — Involvement of notified bodies in conformity assessment proceduresArticle 50 — Mechanism for scrutiny of conformity assessments of class D devicesArticle 51 — Certificates of conformityArticle 52 — Electronic system on notified bodies and on certificates of conformityArticle 53 — Voluntary change of notified bodyArticle 54 — Derogation from the conformity assessment proceduresArticle 55 — Certificate of free saleArticle 56 — Performance evaluation and clinical evidenceArticle 57 — General requirements regarding performance studiesArticle 58 — Additional requirements for certain performance studiesArticle 59 — Informed consentArticle 60 — Performance studies on incapacitated subjectsArticle 61 — Performance studies on minorsArticle 62 — Performance studies on pregnant or breastfeeding womenArticle 63 — Additional national measuresArticle 64 — Performance studies in emergency situationsArticle 65 — Damage compensationArticle 66 — Application for performance studiesArticle 67 — Assessment by Member StatesArticle 68 — Conduct of a performance studyArticle 69 — Electronic system on performance studiesArticle 70 — Performance studies regarding devices bearing the CE markingArticle 71 — Substantial modifications to performance studiesArticle 72 — Corrective measures to be taken by Member States and information exchange between Member States on performance studiesArticle 73 — Information from the sponsor at the end of a performance study or in the event of a temporary halt or early terminationArticle 74 — Coordinated assessment procedure for performance studiesArticle 75 — Review of the coordinated assessment procedureArticle 76 — Recording and reporting of adverse events that occur during performance studiesArticle 77 — Implementing acts